Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Potentiel for sporadic damage reagent cap hinges on different elecsys products lots. in consequence the affected cap may not remain in the correct open position on the instrument during pipetting causing the system probe or bead mixer to hit the cap.